United States Department of Health and Human Services (HHS)

Issuing Organization

Centers for Disease Control and Prevention (Malaria Branch/ DPD/ NCZVED/ CDC), at http://www.cdc.gov/malaria

Participating Organizations

Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov

Components of Participating Organizations

Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NCZVED/ CDC), at http://intranet.cdc.gov/ccid/nczved/

Title: Implementation Research for the Management of Malaria and Childhood Illness in Rural Areas of the United Republic of Tanzania (U01)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

Authority: This program is authorized under sections 301 and 307 of the Public Health Service Act, [42 U.S.C. sections 241 and 242l], as amended.

Announcement Type: New

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance may be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Time on the application submission receipt date (see “Key Dates” below).

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-CK-09-006

Catalog of Federal Domestic Assistance Number(s): 93.283 Centers for Disease Control and Prevention – Investigations and Technical Assistance

Key Dates

Release/Posted Date: September 3, 2008
Letter of Intent Receipt Date: Not Applicable
Application Submission Receipt Date(s): October 3, 2008
Peer Review Date(s): January-February 2009
Council Review Date(s): February-March 2009

Earliest Anticipated Start Date(s): April 1, 2009

Additional Information to Be Available Date: Not Applicable

Expiration Date: Add Information Here

Due Date for E.O. 12372

Due no later than 60 days after the application receipt date.

Additional Overview Content

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
   1. Research Objectives

Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

Section III. Eligibility Information
   1. Eligible Applicants
   A. Eligible Institutions

   2.Cost Sharing or Matching
   3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
   1. Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
   A. Receipt and Review and Anticipated Start Dates
   1. Letter of Intent
   B. Submitting an Application to CDC
   C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
   A. Additional Review Criteria
   B. Additional Review Considerations
   C. Sharing Research Data
   D. Sharing Research Resources

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   A. Cooperative Agreement

1. Recipient Rights and Responsibilities
2. HHS/CDC Responsibilities
3. Collaborative Responsibilities

    3. Reporting

Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NCZVED) of the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) is committed to achieving the health-promotion and disease-prevention objectives of "Healthy People 2010," and to measuring program performance, as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses “Healthy People 2010” priority area(s) of Immunization and Infectious Diseases and Global Public Health, and is in alignment with NCZVED’s performance goal(s) to protect Americans from infectious diseases, provide assistance to endemic-country Ministries of Health and research partners, and conduct health diplomacy. For more information, www.healthypeople.gov. and

http://intra-apps.cdc.gov/fmo/.

In addition this FOA addresses the specific goals of the CDC Malaria Branch to accomplish the following: (1) address the optimal mix of currently validated malaria-control interventions across transmission zones and epidemiological and cultural settings; (2) rapidly develop and validate the impact of revised, enhanced or novel interventions that will contribute to effective malaria control at scale; and (3) establish the most feasible opportunities for integration with other U.S. Government-supported child-survival, environmental-health, vector-control, and infectious-disease programs.

Implementation Research into the Management of Malaria and Childhood Illness in Rural Areas of the United Republic of Tanzania. At the start of the 21st century, malaria remains the single-most important infectious pathogen for child survival in sub-Saharan Africa. HHS/CDC and its research partners in malaria-endemic countries have been at the forefront of establishing the efficacy of proven malaria-control interventions, including insecticide-treated bed nets (ITN); intermittent, preventive treatment of malaria for pregnant women (IPTp); and artemisinin-containing combination treatments (ACT) for symptomatic malaria cases. If implemented broadly, these interventions together could reduce the malaria-attributable mortality among African children by as much as 50 percent. Assuring high coverage of these interventions was a priority in the Global Malaria Control Strategy of 1993; the African Region’s Accelerated Plan for Malaria Control in 1997; the Abuja Declaration for Roll Back Malaria in 2000; and the U.S. President’s Malaria Initiative launched in 2005. However, reaching coverage targets of 60 to 80 percent has been elusive without the benefit of scientific evidence to direct program managers in the best ways forward.

New global initiatives for malaria control, like the President’s Malaria Initiative, have also emphasized interventions, such as indoor residual spraying (IRS), that had fallen out of favor. In addition, researchers in Tanzania and elsewhere in the malaria-endemic world have championed interventions that might be available in the next five to 10 years, including partially effective malaria vaccines, new doses or formulations of artemisinin-containing combination treatments, new insecticides for residual application, and new approaches to the management and control of malaria vectors. In late 2007, the Roll Back Malaria Partnership called on endemic-countries to develop strategies for elimination and post-elimination scenarios. This renewed emphasis on malaria elimination carries with it an obligation for malaria-control programs and their research partners to investigate carefully and to document the ideal mix of malaria-control interventions across settings of diverse and rapidly declining malaria transmission, to identify and document the effectiveness of newly recognized and once-disqualified interventions, and to maximize opportunities for the integrated delivery and management of malaria control in the context of other child-survival and infectious-disease programs. This FOA represents an important opportunity to address these deficiencies and priorities in the context of the President’s Malaria Initiative.

Research Plan Elements

Objective 1: Address the optimal mix of currently validated malaria-control interventions across malaria-transmission zones and diverse epidemiological and cultural settings;

Objective 2: Rapidly develop and validate the impact of revised, enhanced or novel interventions that will contribute to effective malaria control at scale; and

Objective 3: Establish the most feasible and effective opportunities for integration with other U.S. Government child-survival, environmental-health, vector-control, and infectious-disease programs.

The Republic of Tanzania is well-positioned as a laboratory for exploring how the introduction and scale-up of established malaria-control interventions (ITNs, IPTp, and facility-based case-management with ACT) affect the level of malaria transmission in areas formerly subjected to intense, perennial transmission. The introduction and widespread use of ITNs in the Kilombero Valley of Tanzania, and other socio-economic and environmental changes, appears to have reduced the malaria entomological-inoculation rate as much as tenfold. This FOA presents an opportunity to explore additional questions about scaling up existing interventions and the optical mix of initiatives to prevent and treat malaria in settings of declining malaria transmission.

Research supported by this program will specifically address the following goals of the President’s Malaria Initiative: Addressing the optimal mix of currently validated malaria-control interventions across malaria transmission zones and diverse epidemiological and cultural settings in the first funding year. Furthermore, it will support the program’s objective of identifying and exploiting opportunities to integrate the delivery, management and monitoring and evaluation of malaria control with other U.S. Government health interventions. As new or revised interventions appear that could contribute to effective malaria control at scale, HHS/CDC and the awardee may develop additional activities in subsequent funding years.

Applicants must address all of the following research activities to add scientific knowledge to the first-level priority areas. During the first project year applicants must propose to do the following:

Examine the effectiveness and cost-effectiveness of measures to introduce routine, diagnostic testing for malaria with blood-slide microscopy or rapid diagnostic tests;
Enhance access to effective malaria treatment through community-and retail-sector outlets;
Conduct household and community cross-sectional studies to demonstrate the level of prevalence of malaria parasitemia in the presence of scaled-up malaria-control interventions;
Comprehensively describe (through clinical and laboratory cross-sectional surveys with laboratory confirmation) the non-malarial causes of fever, and the effectiveness of the new treatment algorithms for sick children;
Conduct In vivo and in vitro and cohort studies on the efficacy of currently recommended (and likely alternatives) first-line malaria-treatment drugs in children and pregnant women, according to World Health Organization criteria for clinical efficacy and the SYBR green assay for in vitro culture of malaria parasites;
Evaluate the cost and cost-effectiveness of scaling up proven malaria treatments at the District and national levels;
Conduct qualitative studies of health-seeking behavior for malaria and malaria-like illness, and perceptions of scaled-up prevention and treatment interventions; these could include focus-group discussions and individual interviews with community members, health-care workers, traditional and lay healers, and drug retailers;
Establish the frequency and distribution of known, molecular markers for anti-malarial drug resistance in community-and facility-based studies;
Conduct behavior studies of mosquito vectors to examine the impact of deploying synthetic pyrethroid and alternative insecticides for indoor spraying or long-lasting ITNs;
Develop and pilot-test integrated pharmacovigilance systems for detecting adverse drug events;
Assess the impact of interventions to control malaria vectors (IRS, ITNs and larval control, where appropriate) on other insect vectors of public-health importance, and on related illnesses, including lymphatic filariasis;
Conduct studies of malaria prevention and treatment in HIV-infected and exposed individuals, in conjunction with institutions funded by the President’s Emergency Plan for AIDS Relief; and
Conduct demographic surveillance to document long-term trends in all-cause and malaria-specific childhood mortality in the context of scaling up malaria-control interventions.

As evidence and funding become available for specific, additional topics the research plan should include the following, second-level priority issues. In subsequent years, applicants will propose to do the following:

Conduct a comparative evaluation of demographic surveillance and alternative strategies, such as continuous, ongoing surveys, for assessing trends in childhood mortality;
Conduct policy and advocacy mapping to document decision-making for scaling up malaria-control interventions;
Study mathematical modeling of the coverage of malaria-control interventions, entomological outcomes, infectiousness, the prevalence of malaria infection and febrile illness, and health impact;
Conduct a focused evaluation of newly recommended interventions (including rectal artesunate and intramuscular artemether, as well as interventions not yet recognized) to enhance pre-referral and the definitive care of severe, febrile illness in children;
Pilot-test novel technologies, such as cellular telephone and personal data assistants, for collecting and transmitting malaria-surveillance information;
Pilot-test new strategies for active case-detection and the treatment of malaria infections;
Develop and deploy new molecular assays for anti-malarial drug resistance;
Assess new, pharmaceutical regimens for intermittent preventive treatment in pregnant women, infants, children, or other risk groups;
Conduct field studies of mass drug-administration and gametocytocidal treatments for malaria illness; and
Develop and pilot-test projects to promote human and animal health in agricultural communities, both fixed and pastoral.

The applicant should anticipate and address future collaborations with HHS components, including CDC’s Coordinating Centers, the National Institutes of Health, the World Health Organization and with other partners under the President’s Malaria Initiative, including the U.S. Agency for International Development (USAID), to identify opportunities where malaria prevention and treatment interventions or their monitoring and management systems can overlap with those for other major health problems. The research plan should include and address childhood bacterial diseases, such as respiratory infection and meningitis, which can be difficult to distinguish from severe malaria, and can contribute to co-morbidity. In addition, scaled-up malaria-control interventions can provide opportunities for other health interventions, delivered either in households or health facilities. The applicant should prepare studies to explore these opportunities.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U01 activity code.

The HHS/CDC U01 is a cooperative agreement assistance instrument. Under the U01 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The HHS/CDC National Center for Zoonotic, Vector-Borne, and Enteric Diseases intends to commit approximately $650,000 in direct and indirect costs dollars in Fiscal Year (FY) 2009 to fund one application. The average award amount will be $650,000, for direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to five (5) years. An applicant may request up to $650,000 for the first 12-month budget period. The approximate total project period funded amount is $3,250,000. The anticipated start date for new awards is April 1, 2009.

All estimated funding amounts are subject to availability of funds.

CDC will accept and review applications with budgets greater than the ceiling amount.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application (s) if your organization has any of the following characteristics:

HHS/CDC will only provide assistance to the Ifakara Health Research and Development Centre (IHRDC) in Ifakara and Dar es Salaam, Tanzania. The Ifakara Health Research and Development Centre, Tanzania, is the single, sub-Saharan African institution with the combination of specific expertise and experience that meets the requirements for this award. IHRDC is uniquely qualified for this award based on the following experience and capabilities:

IHRDC has already conducted a large-scale evaluation of the effectiveness of ACT for malaria, and engaged in research on the optimum approaches for confronting malaria and childhood pneumonia with support from HHS/CDC;
IHRDC and HHS/CDC have collaborated on at least five of the major malaria research consortia supported by the Bill and Melinda Gates Foundation;
IHRDC is the only health research institution in sub-Saharan Africa, with the appropriate capacity in biomedical, socio-behavioral, and health economic research;
IHRDC is located in an area of very intense malaria transmission, in a country that has adopted a national malaria treatment policy of ACT, where the President’s Malaria Initiative is actively engaged, and where HHS/CDC and HHS/NIH leave an established research presence;
The National Malaria-Control Program in Tanzania has charged IHRDC and CDC with investigating future treatment options;
IHRDC is actively engaged in research activities directly related to the objectives of this FOA, and of the President’s Malaria Initiative, and has the needed experience and capacity;
IHRDC is an internationally respected research institution engaged in malaria research for over a decade and a half;
Investigators at IHRDC have a detailed understanding of the epidemic’s logic patterns and the geographic distribution of malaria in their area, are actively engaged in using state-of-the-art techniques for evaluating anti-microbial drug resistance, and have the needed and proven expertise in socio-behavioral and economic research related to malaria illness;
IHRDC maintains demographic and health-surveillance systems that cover over 135,000 individuals, which allows for measurement of public-health impact of malaria-treatment policies; and
IHRDC has a proven track record in carrying out large-scale, community-based, public-health interventions; in conducting population-level health research; and in providing and assuring the needed laboratory resources and quality to support these interventions and research activities.

2. Cost Sharing or Matching

Cost-sharing or matching funds are not required for this program. If applicants receive funding from other sources to underwrite the source or similar activities, or anticipate receiving such funding in the next 12 months, they must detail how the disparate streams of funding complement each other.

The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc

3. Other-Special Eligibility Criteria

This project will take place in a foreign country (Tanzania). As such, the Tanzanian Government must approve the proposal and submitting organization. To be considered responsive, the proposal MUST include a written invitation to conduct this type of work in Tanzania, or specific project approval, from the Ministry of Health of the United Republic of Tanzania.

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

· Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp

· eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

IMPORTANT: both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Applicants outside the US are required to include a NATO Commercial and Government Entity (NCAGE) number on their CCR registration. See section IV.2. Content and Form of Application Submission, for instructions.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

To find out if an organization is already eRA Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.”
Direct questions regarding the eRA Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email commons@od.nih.gov

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.
Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email: PGOTIM@cdc.gov

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U01 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget).

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

· Charge back of customs and import fees is not allowed.

· Format: every effort should be made to comply with the format specifications which are based upon a standard US paper size of 8.5" x 11".

· Organizations must comply with Federal/CDC policies on human subjects, animals, and biohazards.

· Organizations must comply with Federal/CDC biosafety and biosecurity regulations. See Section VI. 2. Administrative Requirements http://oerdbdev.od.nih.gov/AGS/Admin/BoilerPlate/ShowDraftRFA.cfm, "Cooperative Agreement Terms and Conditions of Award".

· Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment exiting U.S. resources.

NATO Commercial and Governmental Entity (NCAGE) Code are required for foreign organizations only. See below for instructions:

Registrants located outside of the U.S. are required to include an NATO Commercial and Governmental Entity (NCAGE) Code on their CCR registration, or their registration will be considered incomplete. All countries outside of the U.S. need this number, not just NATO countries.
The Code is a five-character ID number used extensively within the federal government. It is used to support a variety of mechanized systems throughout the government and provides for a standardized method of identifying a given facility at a specific location (from CCR Handbook)
The form and instructions can be found at http://www.dlis.dla.mil/Forms/Form_AC135.asp
Additional instructions for completing the form can be found at http://www.dlis.dla.mil/Forms/form_ac135instr.asp
In Block 2 of the form, select the country where your organization is located from a drop-down list. This list currently includes 30 countries; if your country does not appear on the list, choose ‘other.’
Submit the form via the Internet by clicking the ‘Send Request/Envoyez Demande’ button at the bottom of the form.
Once you click on the “Send Request” button, the form is automatically sent for processing to the country you selected in block 2. If you selected ‘Other’ for country, these requests will be processed by the NATO Maintenance and Supply Agency (NAMSA) in Luxembourg.
If you cannot submit this form by Internet, you can obtain an NCAGE by contacting the National Codification Bureau of the country where your organization is located. For a list of addresses, go to http://www.dlis.dla.mil/nato_poc.asp.

For help from within the U.S., call 1-888-227-2423
For help from outside the U.S., call 1-269-961-7766
Email NCAGE@dlis.dla.mil for any problems in getting an NCAGE code

Prior to registering in CCR, insure that your newly assigned NCAGE is listed on the Business Identification Number Cross- Reference System (BINCS) at www.bpn.gov/bincs. If the assigned NCAGE is not listed in BINCS call 269-961-4623 or send a message to NCAGE@dlis.dla.mil.
Note to U.S. submitters: Organizations with an address containing APO, FPO, or AE do not need an NCAGE assigned by an Allied Nation and should not fill out this form. Instead, register in the Central Contractor Registration (CCR) system at www.ccr.gov and you will receive a U.S. CAGE Code.
CAGE codes for U.S. territories like Guam, Puerto Rico, and the Virgin Islands will be assigned by the U.S by registering in CCR.

3. Submission Dates and Times

See Section IV.3.A for details

3. A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not Applicable

Application Submission Receipt Date(s): October 3, 2008

Peer Review Date (s): January-February 2009

Council Review Date (s): February-March 2009

Earliest Anticipated Start Date: April 1, 2009

3.A.1. Letter of Intent

A letter of intent is not applicable to this funding opportunity announcement.

3.B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the SF424 R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via Grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov. The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIMS staff at: 770-488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for HHS/CDC to process and log submissions.

If submitting a paper application, it must be prepared using the SF424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:

Technical Information Management Section – CK09-001

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Phone: 770-488-2700 ET

3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

· If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.

· Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.

· If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

· If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.

· Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness and responsiveness by the Coordinating Center for Infectious Diseases (CCID) and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.

The HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Additional guidance can be found at HHS Grants Policy Statement.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

· Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.

· Reimbursement of pre-award costs is not allowed.

· Subject to availability of funds.

· Specific language for international announcements is posted on the PGO intranet site: http://pgo.cdc.gov/pgo/ViewHome.do

AUDIT REQUIREMENT

Foreign recipients are subject to audit requirements specified in 45 CFR 74.26(d). A non-Federal audit is required, if during the recipients fiscal year, the recipient expended a total of $500,000.00 or more less than one or more HHS awards (as a direct recipient and/or as a subrecipient). The recipient either may have (1) A financial related audit (as defined in the Government Auditing Standards, GPO stock#020-000-00-265-4) of a particular award in accordance with Government Auditing Standards, in those cases where the recipient receives awards under only one HHS program: or, if awards are received under multiple HHS Programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or (2) An audit that meets the requirements contained in OMB Circular A-133. Please forward a completed audit to the following address:

Procurement and Grants Office

Centers for Disease Control and Prevention

Attn: Grants Management Officer

2920 Brandywine Road, MS: K-75

Atlanta, GA 30341

If your aufit was completed in accordance with number (2) above, in addition to the address above, you are required to send a copy of the audit report to:

Department of Health & Human Services

National External Audit Review Center

Lucas Place, Room 514

323 West 8th Street

Kansas City, MO 64105

6. Other Submission Requirements

Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information”.

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.

Applicants’ research plan(s) should address activities they will conduct over the entire project period.

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

· Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

· Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment.

· Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.

· Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”

Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.) Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/CDC Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590,http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

Scientific merit of the proposed project as determined by peer review
Availability of funds
Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CCID in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

· Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score

· Receive a written critique; and

· Receive a second level of review by HHS/CDC CCID

Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each applications.

· Significance

· Approach

· Innovation

· Investigators

· Environment

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the applicant will do the work contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R). .

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R). Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods? The evaluation of the budget should not effect the priority score.

2.C. Sharing Research Data

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

HHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a plan on sharing research resources.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590 http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting .

3. Anticipated Announcement and Award Dates

Earliest anticipated award date is April 1, 2009

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.” The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under consideration for funding for additional information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application.

Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about requirements. For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available Section VIII. Other Information of this document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous copy to the PD/PI at the time of award.

2.A. Cooperative Agreement

The following terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U01 an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the HHS/CDC may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities

The Recipient will have the primary responsibility for the following:

All budgetary issues, including planning, implementing, and reconciliation;
All staff personnel issues with field staff, including hiring, evaluation, recognition and discipline;
Securing all required, in-country project approvals, including institutional review, scientific review and administrative review;
The safety and security of all field staff, equipment and resources;
Implementing all research activities according to established methodologies and designs;
The collection and management of all data;
Making available to HHS/CDC all data generated, upon request, and at a minimum, updating and sharing all data at least every three (3) months;
Applying patent and intellectual-property rights according to 37 CFR Part 401 – “Rights to inventions made by non-profit organizations and small business firms under government grants, contracts and cooperative agreements,” as explained on the following website: http://www.access.gpo.tov/nara/cfr/waisidx_06/37cfr401_06.html.

Recipient Organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities

An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The CDC Project scientist shall have primary responsibility for:

Facilitating the development of the study design and detailed methodologies;
Preparing any needed paperwork and the submission of documents to secure approvals from the HHS/CDC Institutional Review Board and HHS/CDC Institutional Animal Care and Use Committees;
Providing training for project staff on all technical and biosafety issues;
Developing and providing of all laboratory testing equipment and specialized reagents;
Participating in data analysis, the interpretation of results, and the dissemination and publication of results; and
Applying patent and intellectual-property rights according to 37 CFR Part 401 – “Rights to inventions made by non-profit organizations and small business firms under government grants, contracts and cooperative agreements,” as explained on the following website: http://www.access.gpo.tov/nara/cfr/waisidx_06/37cfr401_06.html

Additionally, an HHS/CDC agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.

2.A.3. Collaborative Responsibilities

A Steering Committee will serve as the governing board for this award. Membership will include the HHS/CDC Project Scientist, and HHS/CDC expert resident in Tanzania, a representative of an USAID resident in Tanzania, the PD/PI, and a representative of the Ministry of Health of the United Republic of Tanzania.

3. Reporting

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

1. Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.

Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

Section VII. Agency Contacts

HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Trudy Messmer, Ph.D.

Extramural Research Program

Strategic Science and Program Unit

Coordinating Center for Infectious Diseases

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS C-19

Atlanta, GA 30333

Telephone: (404) 639-3770

Fax: (404) 639-2469

E-mail: TMessmer@cdc.gov

2. Peer Review Contacts:

Shoukat Qari, D.V.M., Ph.D.

Extramural Research Program

Strategic Science and Program Unit

Coordinating Center for Infectious Diseases

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E05

Atlanta, GA 30333

Telephone: (404) 639-8942

FAX: (404) 639-2469

E-mail: SXQ0@cdc.gov

3. Financial or Grants Management Contacts:

Steward Nichols
Procurement and Grants Office
Center for Disease Control and Prevention

U.S. Department of Health and Human Services
Colgate Building, Room 2707
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2788
Fax: (770) 488-2688
Email: shn8@cdc.gov

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2700

Email: PGOTIM@cdc.gov

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable. Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found on at http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Accounting System Requirements

The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment

It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Proof of Non-profit Status

Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

Security Clearance Requirement

All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).

For example:

Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

a. In a timely manner.

b. Completely, and as accurately as possible.

c. To facilitate the broader community.

Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia/index.htm.

Applications must include a copy of the applicant's Data Release Plan. Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.

Conference Disclaimer and Use of Logos

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.

CDC Home Page: http://www.cdc.gov

CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm

CDC Forms Web Page: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm